- If the Institute of Medicine (IOM) has its way, alternative
therapies will soon be subjected to more rigorous government regulation
and oversight. Complementary alternative medicine (CAM) and alternative
therapies will have to be proven to work according to allopathic medical
models. The result, of course, will be that they will be less widely available,
and they will be more expensive. The IOM also wants the federal law exempting
nutritional supplements from being treated like prescription drugs to be
changed so that, in the future, vitamins and herbal supplements will have
to be proven safe and effective according to conventional criteria before
they can be sold to the public. Much like the situation now facing consumers
in Western Europe and Canada, supplements, especially in their current
high concentration or mega-dose form, will be severely restricted, unavailable
in many cases, and prohibitively expensive.
-
- On January 12, the Institute of Medicine, part of the
sprawling quasi-government National Academy of Sciences (NAS), released
a 300-plus page report, Complementary and Alternative Medicine in the United
States, that advances and expands the ongoing mainstream critique of alternative
medicine. The IOM and NAS are the highest level and most prestigious science
and medical public policy think tanks that advise the U.S. government.
Their membership is made up of several thousand conventional experts mostly
drawn from academia. Annually, the NAS, which was formed in the 1860s during
the Civil War, issues over 350 book-length reports on a wide variety of
subjects. [see note 1 below] NAS and IOM reports are generally accorded
the highest credibility by the mainstream media and science and medical
Establishments. Many of the NAS and IOM reports are soon forgotten but
some, touching on hot button issues, are widely read and extremely influential
as they serve as the basis for changes in public policy and legislation
in the U.S. Congress.
-
- Cause for extreme concern
-
- Anyone interested in alternative medicine, in particular
freedom of medical choice without unnecessary government interference,
should be concerned about the IOM's Complementary and Alternative Medicine
in the United States.
-
- The titles of the many mainstream news stories generated
by the report point to some disturbing implications, for example: "Popular
remedies need closer study, report urges"; "Tougher rules urged
for dietary supplements"; "Report Calls for Tougher Oversight
of Alternative Medicine."
-
- The IOM CAM report took two years to research and write,
with the process overseen by an elite panel of mostly conventional medical
authorities. A number of alt med "leaders" contributed to it.
The IOM report follows earlier, similar, years-long studies by other official
agencies, including the Office of Alternative Medicine (1995), the White
House Commission on Complementary and Alternative Medicine Policy or WHCCAMP
(2002), and the Office of Technology Assessment (1990). All of these earlier
efforts explored similar, if not quite identical, themes. There have also
been scores, if not hundreds or even thousands, of similar studies and
articles published in the medical and scientific literature during the
past 10-15 years. (On January 14, a search of keywords "alternative
medicine" at the National Library of Medicine's PubMed returned over
96,000 abstracts of studies published in the MEDLINE-indexed scientific
literature.)
-
- The IOM's 2005 CAM report apparently pleased Stephen
E. Straus, M.D., director of the National Center for Complementary and
Alternative Medicine, the National Institutes of Health entity that originally
commissioned the IOM CAM study. According to a statement by Straus, requiring
the same research standards [for supplements and CAM therapies that conventional
therapies supposedly have to meet, as the IOM recommends] "will further
the scientific investigation of this new field, increase its legitimacy
as a research area and ultimately improve public health."
-
- Targeting nutritional supplements
-
- In its new CAM report, the IOM singled out dietary supplements
as culprits worthy of expanded federal regulation and control. (This follows
up on a 2004 IOM report [see below].) In the face of massive evidence to
the contrary, the 2005 IOM report expressed concern about the quality of
herbal and nutritional supplements, asserting ''there is little product
reliability." The IOM recommended that Congress take steps to require
improved quality control of supplements and to provide incentives to study
the efficacy [emphasis added] of supplements, as well. ''Reliable and standardized
products are needed," Stuart Bondurant, M.D., Interim Executive Vice
President and Executive Dean, Georgetown University Medical Center and
the chair of the committee that prepared the IOM CAM report, said at a
press briefing on January 12. Bondurant also mentioned "evidence based
medicine" in his opening statement. (As noted in an article on December
15, 2004, a new study by the Citizens' Council on Health Care (CCHC) in
Minnesota criticizes evidence based medicine. According to CCHC report
author Twila Brase, R.N., "Evidence-based medicine [EBM] is an attack
on the patient-doctor relationship. EBM is not individualized care. It
is group-think medicine. . .Control over medical decisions is being shifted
from doctors to data crunchers; from professionals at the bedside to bureaucrats
in big offices. . .The public should not be fooled by the nifty-sounding
names. Evidence-based medicine is managed care masquerading as science.")
-
- The only critical response to the IOM CAM report that
could be found online on January 14 was by Annette Dickinson, Ph.D., president
of the Council for Responsible Nutrition (CRN), a dietary supplement industry
trade association. She said in a statement: "The [IOM] dietary supplement
chapter is an unwarranted hatchet job."
-
- In fact, a powerful new campaign to marshall public
and government support for regulating alt med is being developed by anti-alt
med forces (or at least by players who are not sympathetic to primary alternative
medicine) with the complicity of many in the CAM community itself. This
effort entails the allegation that supplements, especially herbs, have
unknown synergistic effects when taken with prescription drugs and that
these "herb-drug interactions" might possibly harm patients.
Further, it is claimed that many if not most of the scores of millions
of Americans who regularly use supplements and herbs do not tell their
doctors what they are doing. The solution, according to the IOM and others
in sync with this way of thinking (including, perhaps surprisingly, many
licensed naturopaths), is to make nutritional supplements and herbs prescription-only,
or at least government-approved, items.
-
- The IOM CAM report also urges that the federal government
require that complementary and alternative medical therapies, including
herbal remedies and acupuncture, meet the same standards of effectiveness
as conventional medical treatments, before they are allowed to be used
clinically. This scenario is exactly opposite to the way alt med has evolved
and grown to this point.
-
- In light of the widely reported failures of the Food
and Drug Administration (FDA), the leading government agency that oversees
and regulates conventional drugs and medical treatments, to do its job
(witness the recent recall of the prescription pain drug Vioxx, alleged
to have caused more than 100,000 deaths and serious injuries despite being
approved by the FDA) [see note 2 below], the recommendations of the IOM
CAM report seem ludicrous in the extreme. Yet, incredibly, they are championed
not only by conventional medical experts but by many leaders in the alt
med field (some of whom contributed to the IOM CAM report).
-
- Joe Pizzorno, N.D., one of the most visible proponents
of naturopathic medicine and widely acknowledged as one of the leaders
of alternative medicine, a founder and past president of Bastyr University
in Bothell, WA (which has received millions of dollars of federal research
grants), for example, commented at a March 26, 2001 WHCCAMP meeting in
Washington, D.C. that nutritional supplement companies should be taxed
in order to give the FDA more power to regulate the supplement industry.
-
- Many licensed naturopaths in both the U.S. and Canada
have recently been contributing, wittingly or otherwise, to the effort
by conventional medicine to shift health care options away from low cost
self-care and personal freedom and responsibility on the part of the patient-consumer
(such as in choosing and obtaining nutritional and herbal supplements)
to the licensed health care professional. For a discussion of this disturbing
trend, see the 2003 article "Are Naturopaths Targeting Health Food
Stores?"
-
- Coincidence or ...?
-
- The issuance of the IOM CAM report at this time is not
an isolated event. Among other coordinated developments, there are efforts
underway in Congress, particularly among Democrats, to overturn the 1994
law (the Dietary Supplement Health Education Act or DSHEA) that has continued
to exempt nutritional supplements from being treated like drugs.
-
- As the Institute for Health Freedom reported in its
January e-mail newsletter, "The National Heart, Lung, and Blood Institute
(NHLBI) announced (on January 10!) that it will hold a conference January
13 and 14, 2005 to evaluate the risks of interactions between dietary supplements
and prescription blood-thinning medications. The NHLBI notes that up to
52 percent of the population reports using dietary supplements and that
four million Americans use blood-thinning medications."
-
- Another study by researchers at Harvard including David
Eisenberg, M.D. (who was also a member of the IOM panel that wrote the
CAM report), supporting the IOM's recommendations, was also published on
January 12 in the journal Alternative Therapies in Health and Medicine.
According to an article in USA Today, that study "found that about
35% of Americans have used some form of alternative medicine. Dr. Hilary
Tindle, lead author of that report, said such widespread use shows the
necessity of studying the safety, efficacy and cost-effectiveness of these
approaches. The biggest change was an increase in use of herbal supplements
over the five years, the study said. Both the Harvard and IOM reports cited
a failure of a majority of consumers using supplements to tell their doctors.
'This is especially critical as more becomes known about the adverse effects
associated with individual dietary supplements as well as their interactions
with prescription drugs,' said Harvard's Tindle."
-
- Alternative medicine is being blamed for its success.
More people are using alternative therapies, truly adverse reports of patient
harm are miniscule, but leaders of conventional medicine insist that alt
med needs to be regulated.
-
- One study that purports to establish potential harm
was published on December 15, 2004 in the Journal of the American Medical
Association (JAMA). The study is "Heavy Metal Content of Ayurvedic
Herbal Medicine Products" and one of its authors is Eisenberg. The
JAMA study asserts that one in five Ayurvedic medical products sold in
Boston-area South Asian grocery stores contains a potentially harmful level
of lead, mercury or arsenic. According to an article published by India
New England on January 1, the study's lead author, Robert B. Saper, M.D.,
M.P.H., director of integrative medicine at the Boston University School
of Medicine, and his study co-authors "are calling on U.S. Congress
to reform regulations of Ayurvedic medicines so the products are tested
for safety." Eisenberg, director of the Harvard Medical School Division
of Research and Education in Complementary and Integrative Medical Therapies,
is quoted as saying: "In order to investigate the efficacy of commonly
used dietary supplements - including Ayurvedic remedies - we need to test
high-quality standardized products free of contaminants and dangerous toxins.
This study reminds us of the need for regulatory reform involving dietary
supplements used by the American public." But the India New England
article noted, "Ayurvedic textbooks describe a therapeutic role for
heavy metals such as mercury and lead. 'It's possible that some of these
products, perhaps those with concentrations of metals that are extremely
high, may have had metals intentionally included,' [Saper] said."
-
- One wonders, too, if it was a coincidence that on the
evening of January 12, the same day the IOM CAM report was released, the
lead story on CBS TV's 60 Minutes (Wednesday) (a segment titled "A
Prescription for Death?") bashed James Shortt, M.D., described as
"a physician on the cutting edge of alternative treatments."
-
- A looming deadline
-
- In e-mail and Web alerts, Citizens for Health notes:
-
- "FDA is reviewing portions of DSHEA, the Dietary
Supplement Health Education Act. The agency may propose new and overly
burdensome regulations that could restrict your access to new dietary ingredients
and dietary supplements that were not on the market prior to 1994 when
DSHEA was passed.
-
- Recall that 2.5 million concerned consumers contacted
Congress between 1992 and 1994 to support DSHEA and assure access to their
supplements. In response to the overwhelming consumer support, Congress
passed DSHEA and deliberately created new and different regulations for
dietary supplements. Congress enacted DSHEA to stop the FDA from treating
dietary supplements like food additives or drugs and to protect consumer's
rights to purchase these products.
-
- We need to make our voices heard once again!
-
- The deadline is February 1, 2005. Send YOUR Letter [to
the FDA] NOW."
-
- The IOM 2004 Report
-
- On April 1, 2004, the Institute of Medicine released
a 370-page report titled Dietary Supplements: A Framework for Evaluating
Safety. Commissioned by the FDA, it was the result of three years' worth
of work by a list of experts in the field and, like the IOM's January 12,
2005 CAM report, it received extensive national media coverage attention.
-
- The 2004 IOM report, in plain English (according to the
headline of one press account), says the "FDA Can Pull Supplements
Without Proof." Another story highlights the report's conclusions:
'The Food and Drug Administration doesn't need direct evidence of human
harm before taking steps to curb sales of a dietary supplement. . .Data
from animals, test-tube studies, even similar products can suffice. . .The
report promises to bolster new FDA efforts to crack down on risky supplements
-- and challenges long-held assumptions that the agency must prove an ingredient
unsafe before pulling it off the market."
-
- Among its many recommendations, the 2004 report calls
on the Congress to increase funding for the FDA to oversee the supplement
industry, including requiring manufacturers to report customers' side effects
to the FDA. To do that, manufacturers would have to establish toll-free
hot lines and publish the contact information on supplement bottle labels.
-
- Even more problematic and expensive for the industry
would be a new requirement that manufacturers would need to provide the
FDA with all information about a supplement before it is marketed. That
data would include animal studies, laboratory tests, and other scientific
information including data about products similar to the new supplement.
-
- The chairwoman of the committee that wrote the 2004
IOM report, Barbara O. Schneeman, a professor of nutrition at the University
of California-Davis, was quoted widely in the media in support of the study
and of the need for regulation. In a reverse of the usual revolving door
in which a top bureaucrat goes from a job in a federal agency to one in
a related industry, less than two weeks after the 2004 report was published,
Schneeman was appointed to head the FDA's Office of Nutritional Products,
Labeling and Dietary Supplements. The office is a component of the FDA's
Center for Food Safety and Applied Nutrition.
-
- The Bigger Picture
-
- The freedom of citizens and consumers in countries of
the European Union (EU) and the United Kingdom to buy and use nutritional
supplements is under siege and that may soon be the case in the United
States. According to the Alliance for Natural Health or ANH (UK) and other
consumer interest groups, "proposals for EU, US and Codex regulation
could destroy natural healthcare."
-
- In a presentation (downloadable in MS Word format) at
the American College for Advancement in Medicine (ACAM) Conference, in
San Diego last November, Robert Verkerk Ph.D., the ANH's executive director,
said: "Many argue that the period between 2004-6 is likely to be the
most critical yet faced by the natural products industry with regard to
regulation. Regulation has the potential to more or less emasculate the
innovative sector of the natural products industry."
-
- According to a message on the Internet,
-
- "In August 2005 everything in Europe is about to
change due to the EU Food Supplements Directive (FSD). Banned items will
include natural vitamins such as mixed tocopherols (natural vitamin E),
carotenoids and b-12 methylcobalamin, all forms of sulphur, boron, vanadium,
silicon and most trace elements, the most readily absorbed and safest forms
of calcium, magnesium, zinc, selenium, chromium and molybdenum. It will
severely limit the doses of vitamins and will remove all high-dose products
from the market. It will include future restrictions on nutrients such
as fatty acids, amino acids, enzymes, probiotics, phytonutrients, etc.
The directive will dramatically limit future innovation in the supplements
industry, and seriously impact retail outlets, complementary practitioners
and consumers who choose to take responsibility for their own health and
let food be their medicine."
-
- In light of the news detailed above and other developments,
alternative medicine as we know it is in serious jeopardy. Increasingly,
according to a harmonized chorus of conventional and CAM mouthpieces, united
by mutual self-interest, ego, and the search for power and economic advantage,
alt med is being presented as dangerous, and people and policy makers are
being warned that alternative therapies, and especially nutritional and
herbal supplements, require major new study (on top of the thousands of
studies already being funded by the NCCAM) as well as drastic new federal
regulation, oversight, and control. People are being told, in effect, that
they are too stupid to take responsibility for their own health and to
make informed decisions without the aid of the federal government or a
licensed medical or health specialist ("CAM" or conventional).
It seems safe to say at this point, Caveat emptor or "alt med consumer
beware."
-
-
- Notes
-
- 1. The National Academy of Sciences 2003 Annual Report
to Congress provides interesting insights into its work. In the health
area, as they conduct research and mobilize support for conventional approaches
to vaccinations, mass screening of the population, drugs for HIV/AIDS,
etc., the NAS and IOM show themselves to be the ultimate politically correct
arbiters of national science and medical thinking.
-
- 2. On January 2, 2005, the Financial Times reported
that David Graham, the FDA employee who blew the whistle on Vioxx (which
resulted in its being taken off the market by its manufacturer last September),
"has vowed to publish research [in the UK medical journal The Lancet]
that suggests up to 139,000 Americans have died or have been seriously
injured as a result of taking the drug [Vioxx]."
-
- http://www.naturalhealthline.com/
|